文章摘要
贾峥,曲守方,高瑛瑛,张文新,孙楠,沈敏,李丽莉,张河战.胱抑素C冰冻人血清国家标准品的建立及溯源性研究[J].中国药事,2024,38(1):38-44
胱抑素C冰冻人血清国家标准品的建立及溯源性研究
Establishment and Traceability Study of Cystatin C Frozen Human SerumNational Standard
投稿时间:2023-04-27  
DOI:10.16153/j.1002-7777.2024.01.005
中文关键词: 胱抑素C  量值溯源  国际标准物质  免疫比浊法
英文关键词: Cystatin C  quantity traceability  international standard material  immunoturbidimetry
基金项目:
作者单位
贾峥 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
曲守方 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
高瑛瑛  
张文新 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
孙楠 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
沈敏  
李丽莉 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
张河战 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
摘要点击次数: 133
全文下载次数: 116
中文摘要:
      目的:对胱抑素C进行量值溯源性研究,研制胱抑素C冰冻人血清国家标准品,建立用于胱抑素C检测试剂盒准确度评价的质量评价标准,提升检验检测水平。方法:以人血清样本为原料进行无菌分装、制备胱抑素C冰冻人血清国家标准品,采用多实验室联合赋值的方法对胱抑素C国家标准品候选品进行赋值、标定,建立可溯源至国际标准物质ERM-DA471/IFCC的溯源链,并采用免疫比浊的方法对其均匀性、稳定性进行验证。结果:建立了包含2个水平量值的胱抑素C冰冻人血清国家标准品,水平1为(0.94±0.03)mg·L-1(k=2),水平2为(3.52±0.09)mg·L-1(k=2)。该国家标准品均匀性和稳定性良好。30天短期稳定性研究结果显示,室温条件下,国家标准品(水平1和水平2)可稳定5天;2~8 ℃条件下,水平1可稳定10天,水平2可稳定20天;-20 ℃条件下,水平1和水平2均至少可稳定30天。溯源准确性采用血清参考盘和临床血清样本进行验证,研究结果显示,该国家标准品和国际标准品ERM-DA471/IFCC具有良好的溯源性。结论:通过对胱抑素C进行量值溯源性研究,研制出胱抑素C冰冻人血清国家标准品(360046-202001),并获得批准向社会提供,可用于人血清中胱抑素C检测试剂盒正确度评价及临床实验室检测系统量值准确性评价。
英文摘要:
      Objective: To carry out a quantitative traceability study on cystatin C, and to develop cystatin Cfrozen human serum national standard, which can be used for evaluating the accuracy of cystatin C test kits,and improving the ability of human serum cystatin C detection. Methods: Human serum samples were used asraw materials for aseptic sub-packaging and preparation of cystatin C frozen human serum national standard.The candidate of cystatin C frozen human serum national standard was assigned and calibrated by the method of multi-laboratory joint assignment, which was traceable to the international standard ERM-DA471/IFCC, and theaccuracy of the traceability chain has been verifi ed. The homogeneity and stability of the national standard wasverifi ed by the method of immune turbidimetry. Results: The cystatin C frozen human serum national standardwas established, which contains two concentration levels: level 1 (0.94 ± 0.03) mg·L-1 (k=2), Level 2 (3.52 ± 0.09)mg·L-1 (k=2); cystatin C frozen human serum national standard has good homogeneity and stability. The resultsof the 30-day short-term stability study showed that cystatin C frozen human serum national standard (level 1 andlevel 2) were stable for 5 days at room temperature; at 2-8 ℃, level 1 can be stable for 10 days and level 2 canbe stable for 20 days. At -20 ℃, both level 1 and level 2 can be stable for at least 30 days. The accuracy of thetraceability was verifi ed by using the serum reference panel and clinical serum samples, study results show that thenational standard and international standard ERM-DA471/IFCC have good traceability. Conclusion: The CystatinC frozen human serum national standard (360046-202001) has been approved and provided to the society withthe quantitative traceability study, which can be used for the accuracy evaluation of the cystatin C detection kit inhuman serum and the accuracy evaluation of clinical laboratory detection system values.
查看全文   查看/发表评论  下载PDF阅读器
关闭